A Phase 4 interventional study of morphine and Patient re-education in Post-operative Pain, sponsored by Clinical Research Centre, Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-08-17.
Sponsored by Clinical Research Centre, Malaysia · Phase 4, Interventional, and Treatment
The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique for postoperative analgesia. Investigators are comparing between patient re-education and the background morphine infusion among patients who fail to achieve satisfactory analgesia using IV-PCA Morphine after laparotomy.
In this study, investigators have a second inclusion criteria for subject recruitment. For subjects who meet this criteria meaning their dynamic pain (when blowing incentive spirometer) is ≥ 4/10 after starting on IV-PCA Morphine will be randomized in to 2 groups. One group will receive patient re--education with an additional background morphine infusion and the other group will receive re--education only.
The second highlight for this study is regarding the background morphine calculation. The background morphine is calculated according to this formula:
Total morphine requirement in the first 24 hours post surgery (mg) = 100 - Age (year) So, the background morphine infusion will be calculated based on subject's age and half of their 24 hours requirement will be infused over 24 hours.
This formula was published by Pamela Macintyre in her paper titled " Age is the Best Predictor of Postoperative Morphine Requirement".
5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 160 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Clinical Research Centre, Malaysia is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Calculate based on patient's age, in mg/hour
Drug: morphine · Behavioral: Patient re-education
Using patient information leaflet
Behavioral: Patient re-education
Investigators use the formula that was published by Pamela Macintyre in her paper entitled "Age is the Best Predictor of Postoperative Morphine Requirements." The estimation for the first 24-hour morphine requirement after surgery is calculated as: 100 - age (year). So, half of the total 24-hour morphine requirement will be infused over 24 hours. e.g. background morphine infusion= (100-Age)/ 2/ 24 (mg/hour)
A similar leaflet will be used to re-educate patient at 4 hour after surgery. The correct method to initiate IV-PCA dose, possible side effects and addiction issue will be explained again and re-emphasized
measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)
use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)
Time frame: 48 hours after surgery
respiratory rate
Time frame: 48 hours after surgery
total accumulative morphine consumption from IV-PCA pump
Time frame: 48 hours after surgery
sedation level
sedation score (0 to 3)
Time frame: 48 hours after surgery
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Clinical Research Centre, Malaysia